Trial | NCT02654106  Report issue

Title

Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    temozolomide ...

  • Study Participants

    65
This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
Study Started
Oct 31
2011
Primary Completion
Nov 30
2015
Study Completion
Nov 30
2015
Last Update
Jun 06
2017

Radiation Fractionated Stereotactic Radiotherapy

The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.

  • Other names: FSRT

Drug Temozolomide

concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2*5d, q28d, 6cycles

  • Other names: TMZ

Refractory Brain Metastases Experimental

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases

Criteria 

Inclusion Criteria:

Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT
the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.
KPS ≥60，or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.
Age: 18-75 years old.
Adequate end-organ function:

WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range

Exclusion Criteria:

Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).
Unable or unwilling to comply with the study protocol.
The expected survival time is less than 3 months.
Patients who are anticipated in other clinical trials of brain metastases.
Patients who has been treated with SRT in other hospitals
Pregnant patients or female patients whose HCG is positive
Unsuitable to participate in study, that in the opinion of the treating physician.
No Results Posted